Posted by Michael Wonder on 12 Jun 2025
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Efficacy was evaluated in ENVISION, a single-arm, multi-center trial in 240 adults with low-grade non-muscle invasive bladder cancer that recurred after prior transurethral resection of bladder tumour and met 1-2 of the following criteria: multiple tumours, a solitary tumour >3 cm, and/or recurrence within 1 year.
